Implantable medical device for lubrication of a synovial joint and method for implanting the device

ABSTRACT

An implantable medical device for lubrication of a synovial joint having a joint cavity is provided. The implantable device comprises a solid lubricant and a feeding device, wherein said feeding device is adapted to feed said solid lubricant into the joint cavity for lubricating the synovial joint.

This application is the U.S. national phase of International ApplicationNo. PCT/SE2010/050801, filed 12 Jul. 2010, which designated the U.S. andclaims the benefit of U.S. Provisional Nos. 61/229,755, filed 30 Jul.2009; 61/229,738 filed 30 Jul. 2009; 61/229,739 filed 30 Jul. 2009;61/229,743 filed 30 Jul. 2009; 61/229,745 filed 30 Jul. 2009; 61/229,746filed 30 Jul. 2009; 61/229,747 filed 30 Jul. 2009; 61/229,748 filed 30Jul. 2009; 61/229,751 filed 30 Jul. 2009; 61/229,752 filed 30 Jul. 2009;61/229,761 filed 30 Jul. 2009; 61/229,767 filed 30 Jul. 2009; 61/229,778filed 30 Jul. 2009; 61/229,786 filed 30 Jul. 2009; 61/229,789 filed 30Jul. 2009; 61/229,796 filed 30 Jul. 2009; 61/229,735 filed 30 Jul. 2009;and which claims priority to Swedish Application Nos.: 0900981-2 filed10 Jul. 2009; 0900957-2 filed 10 Jul. 2009; 0900958-0 filed 10 Jul.2009; 0900959-8 filed 10 Jul. 2009; 0900960-6 filed 10 Jul. 2009;0900962-2 filed 10 Jul. 2009; 0900963-0 filed 10 Jul. 2009; 0900965-5filed 10 Jul. 2009; 0900966-3 filed 10 Jul. 2009; 0900968-9 filed 10Jul. 2009; 0900969-7 filed 10 Jul. 2009; 0900970-5 filed 10 Jul. 2009;0900972-1 filed 10 Jul. 2009; 0900973-9 filed 10 Jul. 2009; 0900974-7filed 10 Jul. 2009; 0900976-2 filed 10 Jul. 2009 and 0900978-8 filed 10Jul. 2009, the entire contents of each of which are hereby incorporatedby reference.

FIELD OF INVENTION

The present invention relates generally to a medical device forimplantation in a joint, and a method of providing said medical device.

BACKGROUND

The synovial joints are the most common types of joints in mammals,provide free movement between the bones they join, and are typical ofnearly all limb joints. They can be compared to mechanical bearings in amusculo skeletal machine. A synovial joint is the meeting point of twobones, movably arranged in relation to each other. The end surfaces ofsaid bones are usually smooth and rounded, and covered by articularcartilage. A synovial membrane encapsulates the joint, forming a jointcavity, which contains synovial fluid. Outside the synovial membrane isa fibrous capsule and ligaments, forming an articular capsule.

A healthy joint is remarkably effective with coefficients of frictionlower than those obtainable with man-made journal bearings (frictionalbearings). Furthermore, the constant process of renewal and restorationof living tissue ensures that a synovial joint have a durability farsuperior to that of any artificial bearing. So far, no artificial jointcan equal the performance of a normal human joint.

There are however both natural and pathological processes leading todeteriorated joint function. With age and wear, the articular cartilagebecomes less effective as a shock absorber and a lubricated surface.Different degenerative joint diseases, such as arthritis,osteoarthritis, or osteoarthrosis, accelerate the deterioration.

Developments in material science, together with modern surgicaltechniques have made it possible to replace one or more of the contactsurfaces, or the entire joint. Due to their weight-carrying function,hip and knee joints are most frequently addressed by surgicalintervention and implantation of artificial components, or jointreplacement surgery.

The lubrication of a healthy joint has been the focus of manyresearchers. Articular cartilage is elastic, fluid-filled, and backed bya relatively impervious layer of calcified cartilage and bone. Thismeans that load-induced compression of cartilage will force interstitialfluid to flow laterally within the tissue and to surface throughadjacent cartilage. As that area, in turn, becomes load bearing, it ispartially protected by the newly expressed fluid above it. This is aspecial form of hydrodynamic lubrication, so-called because the dynamicmotion of the bearing areas produces an aqueous layer that separates andprotects the contact points.

Boundary layer lubrication is the second major low-frictioncharacteristic of normal joints. Here, the critical factor is proposedto be a small glycoprotein called lubricin. The lubricating propertiesof this synovium-derived molecule are highly specific and depend on itsability to bind to articular cartilage where it retains a protectivelayer of water molecules. Lubricin is not effective in artificialsystems and thus does not lubricate artificial joints.

Other lubricating mechanisms have been proposed; some remain underinvestigation. Interestingly, hyaluronic acid, the molecule that makessynovial fluid viscous (synovia means “like egg white”), has largelybeen excluded as a lubricant of the cartilage-on-cartilage bearing.Instead, hyaluronate lubricates a quite different site of surfacecontact-that of synovium on cartilage. The well-vascularized,well-innervated synovium must alternately contract and then expand tocover non-loaded cartilage surfaces as each joint moves through itsnormal range of motion. This process must proceed freely. Were synovialtissue to be pinched, there would be immediate pain, intraarticularbleeding, and inevitable functional compromise. The rarity of theseproblems testifies to the effectiveness of hyaluronate-mediated synoviallubrication.

WO 01/85179 discloses fluid compositions and methods for lubrication ofmammalian joints are disclosed, including both natural and artificialfluids. Synovial fluid acts to lubricate the bearing surfaces of bonesand bone-like structures which are held in frictional contact withinbiological joints. Such fluids may be used to treat arthritic, injured,and diseased joints. Synovial fluid containing a dextran-based hydrogelwith lipids provides enhanced rheological and tribological properties ofsuch a fluid. Phospholipids are particularly useful in dextran-basedcompositions for synovial fluid. One phospholipid that can be usedadvantageously in synovial fluid is dipalmitoyl phosphatidylcholine(DPFC).

Su et al. (Design and Mechanics Simulation of Bionic Lubrication Systemof Artificial Joints, Journal of Bionic Engineering, Volume 3, Issue 3,2006) describe a new structure for artificial joints with a jointcapsule which is designed to overcome the drawback of current prosthesesthat omit many functions of the lubricant and the joint capsule. The newstructure is composed of three component: lubricant, artificial jointand artificial joint capsule. The lubricant sealed in the capsule cannot only reduce the wear of the artificial joint but also prevents thewear particles leaking into the body. Thus, unexpected reactions betweenthe wear particles and body can be avoided completely.

Radin et al. (Joint Lubrication with Artificial Lubricants, Arthritis &Rheumatism, 2005, Vol. 14, 1, 126-129) studied the joint lubricatingproperties, in vitro, in bovine metatarsal-phalangeal joints, ofsilicone fluid, methyl cellulose and polyvinyl-pyrrolidone compared tobuffer, serum and synovial fluid. As has been previously reported,synovial fluid was almost twice as good as serum and buffer, which areequivalent in their joint lubricating qualities. Among the threeartificial lubricants tested, only polyvinyl-pyrrolidone was superior tobuffer or serum as a joint lubricant at 37° C. At 55° C., bothpolyvinyl-pyrrolidone and methyl cellulose had the same effect. At notime was any of the artificial lubricants tested as effective atreducing joint friction as was synovial fluid. Silicone fluid wasconsistently an inferior joint lubricant compared with buffer or serum.It was concluded that effective joint lubrication with artificiallubricants depends on their boundary and hydrophilic properties, ratherthan directly on their flow characteristics

Lubricants can be divided into three groups; gaseous, liquid and solid.For the purposes of this description, a solid lubricant is defined as alubricant being solid and substantially maintaining its shape at bodytemperature and at a pressure and mechanical stress encountered in themammal body, including in the joints of a mammal body.

Most solid lubricants are produced as thin solid films on slidingsurfaces. They are also used as fillers in self-lubricating metallic,ceramic, and polymeric composites. In most cases, a transfer film isfound on the sliding surfaces. For solid lubricant films, strongadhesion is key for long service life.

Boric acid (H3BO3) films, which provide the component surfaces with aself-replenishing solid lubricant, are formed from the reaction of theB2O3 surface (deposited by various conventional methods) on thecomponent surface with the water present in the body of therecipient-patient. Conventional methods that can be employed to depositeither a boron, H3BO3, or B2O3 film on the annuloplasty ring componentsurface include vacuum evaporation (with or without ion bombardment) andsimple oven curing of a thin layer over the implant surface. Theself-lubricating mechanism of H3BO3 is governed by its unique layered,triclinic crystal structure which allows sheets of atoms to easily slideover each other during movement, thus minimizing component wear andfriction.

When present at a sliding surface, solid lubricants function the sameway as their liquid counterparts. Specifically, they shear easily toprovide low friction and to prevent wear damage between the slidingsurfaces. Several inorganic materials (e.g. molybdenum disulfide,graphite, hexagonal boron nitride, boric acid) can provide excellentlubrication. Most of these solids owe their lubricity to a lamellar orlayered crystal structure. A few others (e.g. soft metals,polytetrafluoroethylene, polyimide, certain oxides and rare-earthfluorides, diamond and diamond-like carbons, fullerenes) can alsoprovide lubrication although they do not have a layered crystalstructure.

Certain polymers are also used as solid lubricants because theattractive properties they combine are unavailable in other solidlubricants. Polymers are particularly favored for applications wherecost, weight, corrosion and biocompatibility are the majorconsiderations. In short, solid lubricants have been around for a longtime, and they have been meeting some very important and criticaltribological needs.

UHMW PE is another polymer used widely in total joint replacement (Kurtzet al., 1999). Because of the very long molecules and highly entangledmolecular chains, it provides better wear resistance than PTFE. However,wear of this polymer still poses a major obstacle for the longevity ofthe total joint replacement. Recent effort to solve these problems haveincreased interest in the structure, morphology, and mechanicalproperties of the UHMW PE and in various surface ad structural treatmentprocesses (such as crosslinking).

(Solid lubricants and self-lubricating films, Bharat Bhushan, Moderntribology handbook, Vol. 1, 2000)

Hyaluronan or hyaluronic acid is approved by the FDA for the treatmentof osteoarthritis in a method called visco supplementation. In thistreatment, hyaluronan is injected through the articular capsule and thesynovial membrane, into the joint cavity, supplementing the synovialfluid. While mechanically cushioning the joint, and providing atemporary analgesic effect, this treatment is nevertheless recommendedonly as a last alternative to surgery. The injection is difficult toperform, and painful.

The present inventor set out to develop an implantable device and methodfor the lubrication of joints, in particular synovial joints, includingnatural joints, joints comprising artificial component following partialjoint replacement surgery, and complete artificial joints, followingcomplete joint replacement surgery.

Preferably said solid lubricant comprises hyaluronan (hyaluronic acid)and optionally suitable additives. Hyaluronan is particularly preferred,as this is a nontoxic, noninflammatory biodegradable natural substance.

Hyaluronan is available in different qualities, such as relating topurity, molecular weight and degree of crosslinking. With regard tomolecular weight, many different qualities are available, ranging fromlow molecular weight (LMW) or about 50,000 Da to high molecular weight(HMW) or about 4-6,000,000 Da. An increase in molecular weight resultsin corresponding increase in viscosity, from an oily liquid to agel-like semisolid.

For example WO 01/60868 discloses single phase gels for preventing theformation of surgical adhesions. The gels are prepared by reacting anaqueous solution of a polyanionic polysaccharide, such as hyaluronicacid or carboxymethyl cellulose, with divinyl sulfone, to form a gel,the solution is neutralized, and a solid is precipitated from thesolution. The solid can be redissolved in water to form a gel havingproperties which can be modified to suit a particular application. Usinga similar approach, a hyaluronic acid containing solid can be produced,and inserted in contact with the articular surfaces in a joint, wherethe surrounding aqueous body fluids redissolve the solid, releasinghyaluronic acid to lubricate the joint.

US 2009181058 discloses an injectable or implantable rod-shapedformulation for delivery of osteogenic proteins to treat osteoporoticand/or osteopenic bone are disclosed. The formulation compriseshyaluronic acid derivatives and osteogenic proteins, and optionalexcipients and active ingredients such as a bone resorption inhibitor.

WO 2006/034383 discloses viscoelastic compounds encompassing anycompound having viscoelastic properties including, but not limited to,cellulose polymers and their derivatives (for example hydroxypropylmethyl cellulose) and polysaccharides including, but not limited to,glucosaminoglycans such as hyaluronic acid and synthetic linearpolymers. By way of example, the viscoelastic compound may bechondroitin sulphate, polyacrylamide, collagen, pectin, syntheticpolymer-modified carbohydrate, hyaluronic acid or salts or estersthereof in essentially pure form and dry form, or mixtures of two ormore of these compounds.

Suitable sodium hylauronates may in one aspect have a molecular mass ofat least 5-6 million before sterilization which when dissolved to a 1%(w/w) solution will obtain similar characteristics as Healon® ophthalmicviscoelastic solution (OVD) (available from Abbot Medical Optics, Inc.,Santa Ana, Calif.), or when dissolved to 2.3% (w/w) will resembleHealon® 5′ OVD (available from Abbot Medical Optics, Inc., Santa Ana,Calif.)). The preparation and purification of this type of sodiumhyaluronate and to generate viscoelastic solutions are described in moredetail in U.S. Pat. Nos. 4,141,973 and 6,086,697. Also high viscosity,high molecular mass sodium hyaluronates such as those described in U.S.Pat. No. 5,681,825 (marketed as visco elastic under the trade nameHealon® GV) can be used with the present invention. One of ordinaryskill in the art will realize that in other aspect of the invention,suitable sodium hylauronates may have a lower molecular mass, as low as100,000 Da. Clearly, the desired molecular weight is dependent on theclass of polymer that is desired to be used in association with thepresent invention. By way of example, and not of limitation, suitableviscoelastic solutions may be formed using HPMC in the weight range offrom about 30,000 to about several hundred thousand daltons. Similarly,suitable viscoelastic solutions may be formed using chondroitin sulphatein the weight range starting from about 20,000 to about 30,000. Ingeneral, the molecular weight of the chosen visco elastic compound(whether it is sodium hyaluronate, HPMC or another viscoelastic) will beselected based on the desired visco elastic properties of the finalsolution.

Hip joint Osteoarthritis is a syndrome in which low-grade inflammationresults in pain in the hip joints, caused by abnormal wearing of theCartilage that act as a cushion inside if the hip joint. This abnormalwearing of the cartilage also results in a decrease of the jointslubricating fluid called Synovial fluid. Hip joint Osteoarthritis isestimated to affect 80% of all people over 65 years of age, in more orless serious forms.

The present treatment for hip osteoarthritis comprises NSAID drugs,local injections of Hyaluronic acid or Glucocorticoid to helplubricating the hip joint, and replacing parts of the hip joint with aprosthesis through hip joint surgery.

The replacing of parts of the hip joint is one of the most commonsurgeries to date performed at hundreds of thousand of patients in theworld every year. The most common method comprises placing a metalprosthesis in Femur and a plastic bowl in Acetabulum. This operation isusually done through a lateral incision in the hip and upper thigh andthrough, Fascia Lata and the lateral muscles of the thigh. To get accessto the hip joint, the supporting hip joint capsule attached to Femur andIlium of Pelvis needs to be penetrated, making it difficult to get afully functional joint after the surgery. Femur is then cut at the neckwith a bone saw and the prosthesis is placed in femur either with bonecement or without. Acetabulum is slightly enlarged using an Acetabularreamer, and the plastic bowl is positioned using screws or bone cement.

The surgery typically requires one week of hospitalization due to theincreased risk of infection. The recovery process is on average about 6weeks, but even after this period the patient should not perform anyphysical activates that places large strain on the joint.

SUMMARY

An implantable medical device for lubrication of a synovial joint havinga joint cavity is provided. The implantable device comprises a solidlubricant and a feeding device, wherein said feeding device is adaptedto feed said solid lubricant into the joint cavity for lubricating thesynovial joint.

According to one embodiment, the solid lubricant is adapted to be placedwithin an implantable cartridge having an opening into the joint cavity.An inner diameter of the opening could have substantially the samediameter as the inner diameter of said cartridge.

In some embodiments, the solid lubricant could have thixotropic or shearthinning properties, such that the viscosity of said solid lubricant isreduced when said solid lubricant is exposed to strain in the jointcavity.

According to other embodiments, the solid lubricant compriseshigh-molecular weight hyaluronic acid, which could be crosslinkedhigh-molecular weight hyaluronic acid or hyaluronic acids of at leasttwo different high-molecular weight, crosslinked to form a semisolid orsolid gel.

According to another embodiments, the solid lubricant comprises acrosslinking agent chosen from 1, 2, 3, 4-diepoxybutane, divinylsulfone.

The solid lubricant could be a hydrophilic polymer chosen from syntheticand natural polysaccharides, which could be selected from a groupconsisting of: hydroxyethyl cellulose, carboxymethyl cellulose, xanthangum, chondroitin sulfate, heparin, protein, sulfated protein, syntheticwater-soluble polymers.

According to one embodiment, the protein comprises a protein selectedfrom a group consisting of: collagen, elastin, albumin, and globulin.

According to one embodiment, the sulfated protein could comprise asulfated protein selected from a group consisting of: keratin sulfate,and sulfated aminoglycosaminoglycans.

According to one embodiment, the synthetic water-soluble polymer is asynthetic water-soluble polymer selected from a group consisting ofpolyvinyl alcohol, co-polymers of polyvinyl alcohol, and co-polymers ofpoly-(hydroxyethyl)methacrylate.

According to yet another embodiment, the medical device is adapted to beimplanted in the area of the hip joint, such that said solid lubricantcan be inserted into the joint cavity of the hip joint.

The medical device could be adapted to at least partially be implantedin the caput femur, such that the feeding device can feed the solidlubricant into the hip joint cavity, towards the acetabulum.

According to yet another embodiment, the implantable device is adaptedto be inserted into a bore in the femoral bone, which could be a borefrom the lateral side of the femoral bone, in the region of the majortrochanter, or a bore in the pelvis, such that the feeding device canfeed the solid lubricant into the hip joint cavity, towards the caputfemur. The medical device could for example be adapted to be insertedinto the bore in the pelvis, from the acetabulum side of the pelvic boneor from the abdominal side of the pelvic bone.

According to yet another embodiment, the implantable medical device isadapted to be implanted in the area of the knee joint, such that saidsolid lubricant can be inserted into the joint cavity of the knee joint.

According to yet another embodiment, the medical device is adapted to atleast partially be implanted distally in the femoral bone, such that thefeeding device can feed the solid lubricant into the knee joint cavity,towards the tibia bone.

According to yet another embodiment, the implantable device is adaptedto be inserted into a bore in the distal portion of the femoral bone.

According to yet another embodiment, the medical device is adapted to atleast partially be implanted proximally in the tibia bone, such that thefeeding device can feed the solid lubricant into the knee joint cavity,towards the femoral bone.

According to yet another embodiment, the implantable device is adaptedto be inserted into a bore in the proximal portion of the tibia bone.

According to yet another embodiment, the medical device is adapted to beimplanted in the area of the shoulder joint, such that the solidlubricant can be inserted into the joint cavity of the shoulder joint.

According to yet another embodiment, the medical device is adapted to atleast partially be implanted in the scapula bone, such that the feedingdevice can feed the solid lubricant into the shoulder joint cavity,towards the humerus bone, or implanted in the humerus bone, such thatthe feeding device can feed the solid lubricant into the shoulder jointcavity, towards the scapula bone.

According to yet another embodiment, the medical device furthercomprises a retention member for retaining the medical device inside ofthe bore, the retention member comprises at least one bone contactingportion adapted to press on the bone of the inside of the bore forretaining said medical device in the bore. The retention member could becomprises at least one spring member adapted to exert force on said atleast one bone contacting portion.

The feeding device could according to one embodiment comprises anenergized feeding device, which could comprise a motor.

In other embodiments, the feeding device comprises an elastic member,which could be a spring member or a member of elastic material.

According to yet another embodiment, the feeding is adapted to bepowered by a pressurized gaseous fluid.

According to yet another embodiment, the medical device is adapted tie,at least partially, be placed in a prosthesis comprising at least onejoint surface being adapted for implantation.

The medical device could comprise a cartridge being adapted to beexchanged when said solid lubrication housed inside said cartridge hasended.

In yet another embodiment, the medical device further comprises animplantable sleeve adapted to be placed within a bone of the patient,and further adapted to receive said implantable medical device.

A method for improving the lubrication of a synovial joint of a patientis further provided. The method comprises the steps of drilling orpunching a chamber in a bone of the patient, such that an opening of thechamber is located in the joint cavity, and implanting a medical deviceinto the chamber comprising a solid lubricant.

In one embodiment, the method further comprises the step of implanting afeeding device adapted to feed said solid lubricant into the jointcavity for lubricating the synovial joint.

According to some embodiments the solid lubricant is housed within acartridge, and the step of implanting the medical device could comprisethe step of implanting said cartridge into the chamber.

In some embodiments, the step of drilling or punching a chamber in abone of the patient could comprise the step of drilling or punching achamber in a bone in the area of the hip joint, such that said solidlubricant can be inserted into the joint cavity of the hip joint. Thearea of the hip joint could be in the caput femur or in pelvis.

According to one embodiment, the step of implanting said cartridge intothe chamber could comprise the step of implanting the cartridge into abore created in the caput femur, such that the feeding device can feedthe solid lubricant into the hip joint cavity, towards the acetabulum.

According to yet another embodiment, the step of implanting thecartridge into a bore could comprise the step of implanting the medicaldevice into the bore from the lateral side of the femoral bone, in theregion of the major trochanter.

The step of implanting the cartridge into the chamber could comprise thestep of implanting the cartridge into pelvis from the abdominal side ofthe pelvis, such that the feeding device can feed the solid lubricantinto the hip joint cavity, towards the caput femur.

In yet another embodiment, the step of drilling or punching a chamber ina bone of the patient could comprise the step of drilling or punching achamber in a bone in the area of the knee joint, such that said solidlubricant can be inserted into the joint cavity of the knee joint.

The step drilling or punching a chamber in a bone of the patientcomprises the step of drilling or punching a chamber in the femoral boneor the tibia bone.

In yet another embodiment, the step of implanting the cartridge into thechamber could comprise the step of implanting the cartridge into a borecreated in the femoral bone, such that the feeding device can feed thesolid lubricant into the knee joint cavity.

The step of implanting the cartridge into the chamber could comprise thestep of implanting the cartridge into a bore created in the tibia bone,such that the feeding device can feed the solid lubricant into the kneejoint cavity.

The step of drilling or punching a chamber in a bone of the patientcould comprise the step of drilling or punching a chamber in a bone inthe area of the shoulder joint, such that said solid lubricant can beinserted into the joint cavity of the shoulder joint, and the step ofdrilling or punching a chamber in a bone of the patient could comprisethe step of drilling or punching a chamber in the humerus bone or in thescapula bone.

In yet other embodiments, the step of implanting the cartridge into thechamber could comprise the step of implanting said cartridge into a borecreated in the humerus bone, such that the feeding device can feed thesolid lubricant into the shoulder joint cavity.

The step of implanting the cartridge into the chamber could comprise thestep of implanting the cartridge into a bore created in the scapulabone, such that the feeding device can feed the solid lubricant into theshoulder joint cavity.

According to yet another embodiment, the method further comprises thestep of implanting a retention member for retaining the medical deviceinside of said chamber. The step of implanting the retention membercould comprise the step of implanting the retention member such that theretention member presses on the bone of the inside of the bore forretaining said medical device in the bore.

The step of implanting a feeding device could comprise the step ofimplanting an energized feeding device, which in a further step could beconnected.

The method could further comprise the step of implanting a prosthesiscomprising at least one joint surface being adapted for implantation.

In yet another embodiment, the method could comprise the steps ofcreating an incision in the patient, removing the implanted medicaldevice from the patient, and inserting a new medical device, andsuturing or stapling the incision.

Please note that any embodiment or part of embodiment, feature, method,associated system, part of system described herein may be combined inany way.

BRIEF DESCRIPTION OF DRAWINGS

The embodiments are now described, by way of example, with reference tothe accompanying drawings, in which:

FIG. 1 a is a sectional view of a hip joint;

FIG. 1 b is a sectional view of a collum femur;

FIG. 2 is a sectional view of the femoral bone and the hip joint when abore is created in the femoral bone 5;

FIG. 3 is a sectional view of the femoral bone and the hip joint when amedical device is inserted into the bore in the femoral bone;

FIG. 4 is a sectional view of the femoral bone and the hip joint whenthe solid lubricant has been pressed into the cavity of the hip joint;

FIG. 5 a is a sectional view of the femoral bone and the hip joint whenthe medical device/cartridge is being removed from the bore in thefemoral bone;

FIG. 5 b is a sectional view of the femoral bone and the hip joint whena replacement cartridge is placed in the bore;

FIG. 6 shows the creation of a bore in the distal part of the femoralbone;

FIG. 7 shows the placing of a cartridge in the distal part of thefemoral bone;

FIG. 8 shows the removal of a cartridge in the distal part of thefemoral bone;

FIG. 9 a shows the placing of a replacement cartridge in the distal partof the femoral bone;

FIG. 9 b shows a prosthetic part having a bore in which the medicaldevice is adapted to be placed;

FIG. 10 shows bore locations in the femoral and tibia bone;

FIG. 11 shows the medical device when placed in a bore in the humerusbone;

FIG. 12 shows the creation of a bore in the pelvic bone from theabdominal side of the pelvic bone;

FIG. 13 shows the placing of a medical device in the bore created in thepelvic bone;

FIG. 14 shows the hip joint in section when the solid lubricant has beenpressed into the hip joint cavity;

FIG. 15 shows the removal of the medical device in the direction of theabdominal cavity;

FIG. 16 shows the placing of a replacement cartridge in the bore in thepelvis, from the abdominal side of the pelvic bone;

FIG. 17 a shows a sectional view of the medical device/cartridgeaccording to one embodiment;

FIG. 17 b shows an alternative embodiment of the retention members;

FIG. 17 c shows a sectional view of the medical device/cartridgeaccording to another embodiment;

FIG. 17 d shows a sectional view of the medical device/cartridgeaccording to an energized embodiment;

FIG. 17 e shows a sectional view of a prosthetic part adapted to replacea portion of the femoral bone;

FIG. 18 is an overall view of a human patients body showing the positionof an implanted assembly according to the invention;

FIG. 19 is a side view of a first embodiment of an implanted assemblyaccording to the invention mounted to a body tissue;

FIG. 20 a is a top view of the assembly shown in FIG. 19 havingelliptical shape;

FIG. 20 b is a top view of the assembly shown in FIG. 19 having circularshape;

FIG. 20 c is a sectional view of the assembly shown in FIG. 20 b;

FIG. 21 is an overall view of a human patients body showing an implantedassembly according to the invention connected to an implanted medicaldevice;

FIG. 22 is a block diagram of a control system comprising a controlassembly according to the invention;

FIG. 23 is a sectional view of the control assembly shown in FIG. 19;

FIG. 24 is a block diagram showing the different park of a controlassembly according to the invention;

FIG. 25 is a side view of an alternative embodiment of an implantedassembly according to the invention comprising an injection port; and

FIG. 26 is a side view of yet an alternative embodiment of an implantedassembly according to the invention comprising a pump.

FIG. 27 illustrates a system for treating a disease, wherein the systemincludes an implanted assembly of the invention implanted in a patient.

FIGS. 28-42 schematically show various embodiments of the system forwirelessly powering the implanted assembly shown in FIG. 1.

FIG. 43 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of theimplanted assembly shown in FIG. 1.

FIG. 44 schematically shows an embodiment of the system, in which theimplanted assembly is operated with wire bound energy.

FIG. 45 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the implanted assembly shown in FIG. 18.

FIG. 46 is a circuit for the arrangement shown in FIG. 36, according toa possible implementation example.

FIG. 47 shows the apparatus 1110, a two way pump 1009 and the regulationreservoir 1013.

FIG. 48 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system.

FIGS. 49 a-c show a regulation reservoir placed subcutaneous under thepatient's skin and is operated by pushing the outer surface thereof bymeans of a finger.

FIG. 50 shows a first closed system controlling a second closed system.

FIG. 51 a-c show an implanted medical device 100 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 1052 by supply of hydraulic fluid from the largeradjustable reservoir 1052 in fluid connection with the apparatus 1110.

DETAILED DESCRIPTION

Biocompatible material is to be understood as being a material with lowlevel of immune response. Biocompatible materials are sometimes alsoreferred to as biomaterials. Analogous is biocompatible metals a metalwith low immune response such as titanium or tantalum. The biocompatiblemetal could also be a biocompatible alloy comprising at least onebiocompatible metal.

Form fitting is to be understood as an element having a part or sectionwhich is adapted to enable a mechanical connection of said element to atleast one other element using said part or section. Form fittedstructure is a structure of an element which enables form fitting.

Elasticity is to be understood as a materials ability to deform in anelastic way.

Elastic deformation is when a material deforms under stress (e.g.external forces), but returns to its original shape when the stress isremoved. A more elastic material is to be understood as a materialhaving a lower modulus of elasticity. The elastic modulus of an objectis defined as the slope of its stress-strain curve in the elasticdeformation region. The elastic modulus is calculated as stress/strain,where stress is the force causing the deformation, divided by the areato which the force is applied; and strain is the ratio of the changecaused by the stress.

Stiffness is to be understood as the resistance of an elastic body todeformation by an applied force.

Functional hip movements are to be understood as movements of the hipthat at least partly correspond to the natural movements of the hip. Onsome occasions the natural movements of the hip joint might be somewhatlimited or altered after hip joint surgery, which makes the functionalhip movements of a hip joint with artificial surfaces somewhat differentthan the functional hip movements of a natural hip joint.

The functional position of an implantable medical device or prosthesisis the position in which the hip joint can perform functional hipmovements.

Functional hip joint is a hip joint that can perform functional hipmovements either with or without an implanted medical device orprosthesis.

In the following a detailed description of embodiments will be given. Inthe drawing figures, like reference numerals designate identical orcorresponding elements throughout the several figures. It will beappreciated that these figures are for illustration only and are not inany way restricting the scope. Thus, any references to direction, suchas “up” or “down”, are only referring to the directions shown in thefigures. Also, any dimensions etc. shown in the figures are forillustration purposes.

The functional position or normal functional position, of an implantablemedical device or prosthesis is the position in which the hip joint canperform functional hip movements. The final position is to be understoodas a functional position in which the medical device needs no furtherposition change.

The medical device according to any of the embodiments could comprise atleast one material selected from a group consisting of:polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA) and fluorinatedethylene propylene (FEP). It is furthermore conceivable that thematerial comprises a metal alloy, such as cobalt-chromium-molybdenum ortitanium or stainless steel, or polyethylene, such as cross-linkedpolyethylene or gas sterilized polyethylene. The use of ceramic materialis also conceivable, either solely in the contacting surfaces, or in theentire medical device, suitable ceramic materials could be zirconium orzirconium dioxide ceramics or alumina ceramics. The part of the medicaldevice in contact with human bone for fixation of the medical device tohuman bone could comprise a poorhouse structure which could be a porousmicro or nano-structure adapted to promote the growth-in of human bonein the medical device for fixation thereof. The porous structure couldbe achieved by applying a hydroxy-apatite (HA) coating, or a roughopen-pored titanium coating, which could be produced by air plasmaspraying, in further embodiments a combination of a rough open-poredtitanium coating and a HA top layer is also conceivable. The contactingparts could according to some embodiments be made of a self lubricatedmaterial such as a waxy polymer, such as PTFE, PFA, FEP, PE and UHMW PE,or a powder metallurgy material which could be infused with a lubricant,which is preferably a biocompatible lubricant, such as a Hyaluronic acidderivate. It is also conceivable that the material of contacting partsor surfaces of the medical device herein is adapted to be constantly orintermittently lubricated in accordance with several of the embodimentsdisclosed herein. In yet other embodiments parts or portions of themedical device could comprise a combination of metal materials and/orcarbon fibers and/or boron, a combination of metal and plasticmaterials, a combination of metal and carbon based material, acombination of carbon and plastic based material, a combination offlexible and stiff materials, a combination of elastic and less elasticmaterials, Corian or acrylic polymers.

FIG. 1 shows the hip joint of a human patient in section. The hip jointcomprises a caput femur 5 placed at the very top of collum femur 6 whichis the top part of the femoral bone 7. The caput femur is in connectionwith the acetabulum 8 which is a bowl shaped part of the pelvic bone 9.Both the caput femur surface 10 and the acetabulum surface 11 is coveredwith articular cartilage 13 which acts as a cushion in the hip joint. Inpatients with hip joint osteoarthritis, this articular cartilage 13 isabnormally worn down due to a low grade inflammation. The hip joint issurrounded by the hip joint capsule 12 which provides support for thejoint and hinders luxation. After conventional hip joint surgery,penetrating the hip joint capsule 12, the capsule 12 is dramaticallyweakened due to the limited healing possibilities of its ligamenttissue. By not having to perform a total hip joint replacement the hipjoint capsule 12 can remain intact.

The femoral bone, as well as most other bones in the human bodycomprises cortical bone, the outer dense, sclerotic bone, and cancellousbone comprised of a less dense cell structure comprising the bonemarrow.

FIG. 1 b shows a cross-section of the collum femur (6 in FIG. 1 a)displaying the cortical bone 601 and the cancellous bone 602, thecortical bone 601 thus enclosing the cancellous bone 602.

FIG. 2 shows the step of creating a bore in the femoral bone from thelateral side of the thigh using an orthopedic drill 2301. The borepenetrates the most proximal part of the femoral bone, being the caputfemur 5 and thus reaches the synovial area of the hip joint comprisingthe contacting surfaces of caput femur 5 and acetabulum 8, the synovialarea being the area in which the synovial fluid is present.

FIG. 3 shows the step of inserting an implantable device being acartridge 2302 comprising a solid lubricant 2303 housed within the walls2304 of the cartridge 2302. The solid lubricant being adapted tolubricate the contacting surfaces of the acetabulum 8 and the caputfemur 5. The bottom portion of the cartridge 2302 comprises a feedingdevice adapted to feed the solid lubricant, here comprising a springmember 2306 which presses on a bottom plate 2310 disposed within thecartridge 2302, further pressing the solid lubricant 2303 through thecartridge 2302 and in the synovial area for lubricating said contactingsurfaces. The spring member 2306 is in contact with the dividing wall2307 of the cartridge, on the other side of the dividing wall 2307 ofthe cartridge 2302 a retention member 2308 for retaining the cartridge2302 in the femoral bone is disposed. The retention member comprises twospring loaded bone engaging members 2311 engaging the inside of the borewhen the cartridge 2302 is fully inserted into the bore and thusrestrains the cartridge 2302 within the bore (shown in FIG. 4). Thesolid lubricant could comprise high-molecular weight hyaluronic acid.Hyaluronan is available in different qualities, such as relating topurity, molecular weight and degree of crosslinking. With regard tomolecular weight, many different qualities are available, ranging fromlow molecular weight (LMW) or about 50,000 Da to high molecular weight(HMW) or about 4-6,000,000 Da. An increase in molecular weight result incorresponding increase in viscosity, from an oily liquid to a gel-likesemisolid. Suitable sodium hylauronates may in one aspect have amolecular mass of at least 5-6 million before sterilization which whendissolved to a 1% (w/w) solution will obtain similar characteristics asHealon® ophthalmic viscoelastic solution (OVD) (available from AbbotMedical Optics, Inc., Santa Ana, Calif.), or when dissolved to 2.3%(w/w) will resemble Healon® 5′ OVD (available from Abbot Medical Optics,Inc., Santa Ana, Calif.)). The preparation and purification of this typeof sodium hyaluronate and to generate viscoelastic solutions aredescribed in more detail in U.S. Pat. Nos. 4,141,973 and 6,086,697. Alsohigh viscosity, high molecular mass sodium hyaluronates such as thosedescribed in U.S. Pat. No. 5,681,825 (marked as viscoelastic under thetrade name Healon® GV) can be used with the present invention. One ofordinary skill in the art will realize that in other aspect of theinvention, suitable sodium hylauronates may have a lower molecular mass,as low as 100,000 Da. Clearly, the desired molecular weight is dependenton the class of polymer that is desired to be used in association withthe present invention. By way of example, and not of limitation,suitable viscoelastic solutions may be formed using HPMC in the weightrange of from about 30,000 to about several hundred thousand daltons.Similarly, suitable viscoelastic solutions may be formed usingchondroitin sulphate in the weight range starting from about 20,000 toabout 30,000. In general, the molecular weight of the chosenviscoelastic compound (whether it is sodium hyaluronate, HPMC or anotherviscoelastic) will be selected based on the desired viscoelasticproperties of the final solution.

The solid lubricant could comprise a crosslinking agent chosen from 1,2, 3, 4-diepoxybutane, divinyl sulfone further containing a hydrophilicpolymer chosen from synthetic and natural polysaccharides, such ashydroxyethyl cellulose, carboxymethyl cellulose, xanthan gum,chondroitin sulfate, heparin, proteins of various types, such ascollagen, elastin, albumin, a globulin, etc., or sulfated pro bins suchas keratin sulfate and sulfated aminoglycosaminoglycans, syntheticwater-soluble polymers, such as polyvinyl alcohol and its co-polymers,co-polymers of poly-(hydroxyethyl)methacrylate and the like.

FIG. 4 shows the implantable medical device when a portion of the solidlubricant 2303 has been pressed into the synovial area of the hip forlubricating the hip joint. The spring loaded cartridge maintains apressure in the synovial area and as some of the solid lubricant overtime is resorbed by, or diffuses through the encapsulating tissue of thehip joint, new lubricant is added from the portion still housed withinthe cartridge by means of the spring member 2306.

According to one embodiment the solid lubricant has thixotropic or shearthinning properties such that the strain which is placed on the exposedportion of the solid lubricant alters the viscosity of the solidlubricant for creating a well functioning lubricant.

FIG. 5 a shows the hip joint in section when the all of the solidlubricant in the cartridge 2302 has been pressed into the synovial areaof the joint. Depending on the degree of damage on the joint and theparticular patient this could take from a number of weeks to severalyears, after which the cartridge 2302 needs to be replaced or refilled.In FIG. 5 the process of removing the cartridge 2302 is shown. Anincision has been performed on the lateral side of the thigh, beneaththe greater trochanter 2312, through which incision the cartridge 2302can be removed.

FIG. 5 b shows the placing of a replacement cartridge 2302 into thebore. The replacement cartridge 2302 carries more solid lubricant 2303adapted to lubricate the joint surfaces of the hip joint.

FIGS. 6-10 shows an embodiment in which the principle disclosed withreference to FIGS. 2-5 is applied to the knee of a patient. FIG. 6 showsthe creation of a bore in the distal part of the femoral bone 7 using anorthopedic drill 2301. The bore is created through an incision from theposterior side of the femoral bone 7. The bore reaches the surfaces ofthe knee joint, i.e. the distal surface of the femoral bone 5 and theproximal surface of the tibia bone 40.

FIG. 7 shows the insertion of a cartridge 2302, according to any of theembodiments disclosed herein, in the bore created in the distal portionof the femoral bone 7.

FIG. 8 shows the removal of the cartridge from the bore in the femoralbone 7, after the cartridge 2302 has been used such that little or nosolid lubricant 2303 remains in the cartridge 2302.

FIG. 9 a shows the placing of a replacement cartridge 2302 into thebore. The replacement cartridge 2302 carries more solid lubricant 2303adapted to lubricate the joint surfaces of the knee joint.

FIG. 9 b shows the cartridge 2302 when inserted into a prosthetic hipjoint surface 41 adapted to replace the contacting surface of thefemoral bone 7. The medical device here being adapted to lubricate thesurface between the prosthetic hip joint surface 41 and the natural hipjoint surface of the tibia bone 40 or another prosthetic surface adaptedto replace the tibia 40 contacting surface.

FIG. 10 shows the femoral bone 7 and tibia bone 40 in a frontal view.Two bores 42 a,b have been made in the femoral bone 7 and one bore 42 chas been made in the tibia bone. These bores are examples of differentlocations in which the medical devices can be placed. In someembodiments in is further conceivable that several medical devices areneeded to lubricate one joint.

FIG. 11 shows an embodiment in which the cartridge 2302, according toany of the embodiments herein, containing the solid lubricant 2303, isplaced in a bore in the humerus bone 45 for lubricating the shoulderjoint of a patient using the solid lubricant.

FIG. 12 shows the hip joint in section in an embodiment in which a boreis created in the pelvic bone 9 by means of an orthopedic drill 2301.

FIG. 13 shows the placing of a cartridge 2302 containing solid lubricant2303 in the pelvic bone 9. The solid lubricant 2303 is in accordancewith the other embodiments disclosed herein adapted to lubricate thesurfaces of acetabulum 8 and the caput femur 5.

FIG. 14 shows the implantable medical device when a portion of the solidlubricant 2303 has been pressed into the synovial area of the hip forlubricating the hip joint. The spring loaded cartridge 2302 maintains apressure in the synovial area and as some of the solid lubricant overtime is resorbed by, or diffuses through the encapsulating tissue of thehip joint, new lubricant is added from the portion still housed withinthe cartridge by means of the spring member 2306.

According to one embodiment the solid lubricant has thixotropic or shearthinning properties such that the strain which is placed on the exposedportion of the solid lubricant alters the viscosity of the solidlubricant for creating a well functioning lubricant.

FIG. 15 shows the hip joint in section when the all of the solidlubricant in the cartridge 2302 has been pressed into the synovial areaof the joint. Depending on the degree of damage on the joint and theparticular patient this could take from a number of weeks to severalyears, after which the cartridge 2302 needs to be replaced or refilled.In FIG. 15 the process of removing the cartridge 2302 through theabdominal cavity is shown.

FIG. 16 shows the placing of a replacement cartridge 2302 into the bore.The replacement cartridge 2302 carries more solid lubricant 2303 adaptedto lubricate the joint surfaces of the hip joint.

FIGS. 17 a-17 e shows the cartridges in further detail. FIG. 17 a showsan embodiment in which the cartridge comprises an ejection device 2340for affecting the retention member comprising a resilient membrane 2351affecting to spring loaded members 2352 which in turn affects boneengaging members 2311. In normal operation the bone engaging members2311 makes sure that the cartridge remains secured in the bore, and whenthe resilient member is pressed the bone engaging members 2311 foldssuch that the cartridge can be removed from the bore.

FIG. 17 b shows an alternative embodiment of the retention membercomprising bone engaging members 2353, in which the bone engagingmembers 2353 are adapted to be placed in a grove in the bore forretaining the cartridge inside the bore. The alternative bone engagingmembers 2353 are spring loaded in radial direction and the

FIG. 17 c shows an alternative embodiment in which the feeding devicecomprises elastic members 2354, preferably made from elastic material,propels the bottom plate 2310 feeding the solid lubricant 2303, out ofthe cartridge.

FIG. 17 d shows the medical device according to an embodiment comprisinga feeding device in which the bottom plate 2310 is propelled by anenergized operation device, such as an electric motor 2355. The electricmotor is connected to the bottom plate 2310 by means of a threadedmember 2356 engaging a corresponding threaded part of the motor 2355.

FIG. 17 e shows an embodiment of a prosthetic part 2360 adapted to befixated to the femoral bone and replace the contacting surface of thecaput femur. The prosthetic part 2360 is adapted to receive the medicaldevice according to any of the embodiments herein in a bore 42 in theprosthetic part 2360. The prosthetic part 2360 comprises a groove 2358in the bore 42 adapted to receive the bone engaging members 2353according to the embodiment disclosed in FIG. 17 b for retaining themedical device or cartridge in the bore 42.

In embodiments where the medical device comprises an energized unit,such as the motor 2355 disclosed with reference to FIG. 17 d a unit forpowering and/or controlling the medical device could be necessary, anexample of such a unit suitable for this purpose will now be disclosed.The unit is preferably connected to the medical device by means ofelectrical leads and/or hydraulic conduits.

The term “functional parts” is to be interpreted as all parts of thecontrol assembly for the electrical or hydraulic operation of theassembly.

FIG. 18 shows the body of a human patient 1. A control assembly 1110adapted for controlling an implanted medical device is shownsubcutaneously implanted in the abdominal area of the patients body.Although a specific position for the control assembly is shown in thefigure, it will be appreciated that the control assembly can be providedessentially anywhere in the patients body, preferably relatively closeto the implanted medical device which it is adapted to control.Generally speaking, the energy receiver 1110 may be placed in theabdomen, thorax, muscle fascia (e.g. in the abdominal wall),subcutaneously, or at any other suitable location.

An overall side view of the control assembly 1110 is shown in FIG. 19.The control assembly comprises a first unit 120 subcutaneously implantedat a first side of a body tissue 103 in the patient, such as the rectusabdominis muscle running vertically on each side of the anterior wall ofthe human abdomen. In other words, the first unit is positioned betweenthe skin 105 of the patient and the body tissue 103.

A second unit 130 is implanted in a body cavity 107 of the patient at asecond side of the body tissue 103, i.e., that the side opposite of theside at which the first unit 120 is provided.

The first 130 and/or second units 140 preferably have circular orelliptical cross-sectional shape when viewed from outside the patientsbody, see FIGS. 20 a, 20 b, showing a top view of the assembly havingelliptical and circular shape, respectively. Combined with a smoothlycurved sectional shape, this avoids any sharp corners on the units 130,140, which could cause injuries to the patient in which the controlassembly 1110 is implanted.

An interconnecting device 140 constitutes a mechanical interconnectionbetween the first and second units 120, 130 so that the assembly 1110 iskept in place by the body tissue 103. The interconnecting device has across-sectional area which is smaller than the cross-sectional area ofthe first unit and the second unit in a plane parallel to the extensionof the body tissue. In this way, a hole 103 a in the body tissue 103through which the interconnecting device 140 extends can be sufficientlysmall so that it is avoided that one or the other of the units 1110, 120“slips through” the body tissue 103. Also, the cross-sectional shape ofthe interconnecting device 1040 is preferably circular so as to avoiddamage to the body tissue 103.

The interconnection device 140 can be integral with one of the first andsecond units 1110, 120. Alternatively, the interconnection device 140 isa separate part, which is connected to the first and second units 110,120 during implantation of the control assembly 110.

In a preferred embodiment, the interconnection device 140 is hollow soas to house various wires, hoses etc. electrically or hydraulicallyinterconnecting the first and second devices 120, 130.

Alternatively or additionally, the interconnection device 140 is made ofan elastic material, such as rubber, so that the control assembly 110can adapt to the movements of the patient in which it is implanted.

The control assembly 1110 is adapted to control a powered implantedmedical device 100, see FIG. 21. The implanted medical device can be anykind of powered operation device, such as a hydraulically, pneumaticallyor mechanically powered operation device, such as the motor disclosedwith reference to FIG. 17 d. The medical device 100 can be any kind ofimplant, such as a constriction device adapted to constrict and releasea bodily lumen or vessel, a stimulation device adapted to electricallystimulate a bodily organ, an inflatable device adapted to fill forexample the corpora cavernosa of the patient etc. The implanted medicaldevice is preferably very small, having a diameter of less than 5centimeters, to fit in the different target areas of the body.

Depending of the kind of power required to control the medical device100, an interconnection 102 in the form of an electrical wire, apneumatic hose etc., is provided between the control assembly 10 and themedical device 102.

The control unit 10 is adapted to receive energy, preferably wirelessenergy, transmitted from an external energy source or energizer 110located outside the skin in the vicinity of the control unit 10. Theenergizer 110, which is an external device which functions as thecharging equipment and control device for the control assembly, isconnected via a connection, such as a serial RS232 connection, to acomputer 112, such as a standard desktop PC or a laptop computer. The PCsoftware implements the user interface to the implant system, andfunction as the control unit and read back unit of the implant system.

A block diagram of the implant system is shown in FIG. 22. Energy istransferred by means of the wireless coupling between an energizer coil110 a forming part of the energizer 110 and a control assembly coil 10 aforming part of the control assembly 10. Similarly, control informationis transferred between the energizer 110 by means of a wirelesscommunications interface comprising an energizer antenna 110 b formingpart of the energizer 110 and a control assembly antenna 10 b formingpart of the control assembly 10. In this way, both energy andcommunication information can be transferred wirelessly to and from thecontrol assembly 10.

Although separate devices are shown for transfer of energy andinformation, i.e., the coils and the antennas, respectively, it will beappreciated that the coils 10 a, 100 a can be implemented for use as anantenna as well, whereby control information can be transferred by meansof the coils and no separate antennas are needed for that purpose.

The functional park of the control assembly 1110 can be provided eitherin the first unit 120 or in the second unit 130 or in both the first andthe second unit. In other words, at least one of the first and thesecond unit is adapted to control a powered implanted medical device.

FIG. 23 is a sectional view of the control assembly 1110 showing anexample of the contents of the first unit 120, the second unit 130 andthe interconnection device 140. It is also shown that theinterconnection device 140 is provided integral with the first unit 120,forming an extension from the central portion of the first unit. Theouter end of the extension is provided with baths 142 engaging the rimof a hole 122 provided in the central portion of the second unit. Inthis way, the assembly 1110 can be assembled by a simple snap-togetheroperation, as will be described in more detail below.

Coil 150

A coil 150 is provided in the first unit, the coil being an energytransfer coil arranged to pick up wireless electro-magnetic energy andsignals from an external unit. The number of rounds in the coil isadapted for the specific operation and is preferably at least ten. Theend portions of the coil 150 extend perpendicularly to the generalextension of the coil and are lead through the hollow interconnectiondevice 140 to be connected to the functional park provided in the secondunit 130, shown as a block diagram in FIG. 24. The functional park shownin this figure is a non-limiting example of the different partscomprised in a control assembly according to the invention.

MCU 52

A micro controller unit (MCU) 152 is provided as a main controller unitof the control assembly 1110 and it thus provided with control softwarefor controlling the operation of the functional part of the controlassembly. In a preferred embodiment, this MCU is a Texas InstrumentsMSP430F149 MCU. Although not shown in the figure, the MCU can besupplemented by additional peripheral circuits, such as a gate arrayimplemented as an application specific integrated circuit (ASIC), actingas an interface to the various functional part.

The MCU 152 receives commands from the energizer 110 via a wirelesscommunication link, see below, and takes decision about actions. The MCU152 thus supervises all functions in the control assembly 1110.

The MCU stores application specific parameters and calibration data inan external EEPROM (not shown).

The main functionality of the control assembly 1110 is that alloperations, such as stimuli, adjustment or measurements are initiatedvia the energizer 110. Thus, the energizer has two main functions: Userinterface via RF communication with the control assembly 110 and energytransfer to the control assembly.

The control assembly 110 can be OFF or in Standby when “unconnected”.All functions within the control assembly are controlled via thewireless communication link.

The energy transfer function runs in the background as soon as the userhas initiated a charge operation. The coupling between the energizer andthe receiver coil is displayed by means of a graphical user interface(GUI) on the display of the energizer 110.

If the communication is interrupted under operation, the active functionis terminated with a warning message. As soon as correct connection isobtained the last function can be re-activated from the GUI.

Charge Control Unit 154

The MCU 152 is connected to a charge control unit 154, which in turn isconnected to the coil 150, which in this embodiment is provided in thefirst unit 120. The charge control unit comprises an energy storagecapacitor 154 a, from which the normal power supply is taken. In thepreferred embodiment, the energy storage capacitor 154 a has a value ofat least 300 Farad with a maximum voltage of 2.3V. The energy storagecapacitor is normally connected to the energy transfer coil 150,preventing hazardous voltages to occur at the supply circuits. Thevoltage from the energy transfer coil 150 is rectified by means ofhalf-wave rectification.

The transferred energy is set by the voltage on the energizer transmitcoil 110 a, see FIG. 5, and the geometric placement relative the energytransfer coil 1110 a on the control assembly. The leakage inductancesmake the behavior of a current generator, that is, the voltage acrossthe energy storage capacitor 154 a will have a very little influence onthe current.

The charge function is controlled from the energizer software, whichdepends on current and voltage readings on the reservoir capacitor.

The applied energy transfer will charge the capacitor up to a limitvoltage, which in the preferred embodiment is 2.3V, while the chargecurrent preferably is limited to 2 A by the energizer design. If theenergy storage capacitor energy drops below a lower limit voltage, inthe preferred embodiment 1.2V, MCU 152 will be notified to terminate anyactivity and go to STAND-BY mode.

An over voltage protection will disconnect the receiver inductor if theenergy storage capacitor voltage reaches 2.35V. All functional parts ofthe control assembly will still be supplied from the capacitor and abattery charge process will continue.

Thus, the voltage will vary between 1.0 and 2.3V dependent of the chargestatus. This voltage feeds a switch converter for supplying the MCUincluding any gate array. It is preferred that the gate array supply maybe shut down by the MCU to save energy.

The control assembly shall be functional for 36 hours relying on thecapacitor only.

A chargeable battery 154 b is also provided as part of the chargecontrol unit 154. The capacity of the battery is preferablyapproximately ten times that of the energy storage capacitor 154 a. Inthe preferred embodiment, the battery used is three 1.2 V batteries,such as Varta V500-HT, connected in series. This gives a nominal voltageof 3.6V. The battery management consists of two main activities:Charging and de-charging (transfer energy to the reservoir capacitor.Normally the battery is unused and energy is supplied from thecapacitor.

A battery charging functionality is implemented in hardware withsupervision and control from the MCU 52. The chargeable battery ischarged from the energy storage capacitor 154 a when the voltage acrossthe energy storage capacitor exceeds 1.9V. This limit will prevent thebattery charger from emptying the capacitor energy When the voltageacross the energy storage capacitor is less than 1.3V, the battery willcharge the energy storage capacitor a constant current by means of astep-down converter (not shown). The charge current is in the preferredembodiment 350 mA with dv/dt detection.

Temperature supervision will turn off any charge operation if thebattery temperature increases more than 0.7 degrees per min.

The energy transfer is controlled from the software in the computer 112.The MCU 52 will read the voltage and current on the energy storagecapacitor 154 a. The values are then on command transmitted to thecomputer 112, which controls the energizer. If the energy storagecapacitor 154 a has a 300 F capacitance and the charge current isnormally well below 2 A, the voltage changes will be very slow-minutesfor a 0.1V increase. This slow behavior makes an ordinary PI-regulatorsuperfluous. The preferred embodiment is an on/off regulator with a 100mV hysteresis gap.

At the very startup when there may be no energy in the capacitor. Aspecial bypass power will turn on the MCU/transceiver. Thus the feedbackcommunication system will be active almost immediately when theenergizer coil is applied.

Power Modes

The control assembly 1110 can be in four different power modes, namely:

OFF: All circuit are turned off. The transceiver 156 is powered frombattery 54 b, but in sleep mode.

WAKE-UP: The power is fee from the energy transfer coil 150,unconditionally of the status of the capacitor 154 a or the battery 154b. This makes the control assembly to respond immediately when theenergizer is applied.

STAND-BY: MCU active but no stimuli, sensor or motor voltage active.

ACTIVE: The MCU in operation. Motor/Sensors/Stimuli etc. active

The mode is controlled by the software in the MCU.

Transceiver 156

The MCU 152 communicates with the energizer by means of the antenna 1110b, see FIG. 22, which is electrically connected to a transceiver 156 inthe control assembly 1110. The transceiver 156 is in turn connected tothe MCU 152. The transceiver 156 can be any suitable transceiver circuitand is in the described embodiment a circuit marked under the nameZL70101 by Zarlink Semiconductor Inc. This provides RF communicationusing the MICS standard. The transceiver preferably uses a serialperipheral interface (SPI) to communicate with the MCU and is specifiedfor 2.1-3.6V supply. The transceiver needs to be under continuous powerbut have a low power mode with very low quiescent current where it canbe woken up by using either by toggling a wakeup input or alternativelyby MICS band or 2.4 GHz radio signals.

Antenna 1110 b

In the preferred embodiment, the antenna 1110 b is adapted to supportMICS telemetry that operates in the dedicated 402-405 MHz band. The mostprobable implementation of the transceiver 156 will use a system thatcan be implemented using also a secondary 2.4 GHz ISM band for wake uppurposes, which will then also require attention to safeguard antennafunctionality also at these frequencies. The wake up antenna is assumedto be identical to the MICS antenna since alternate solutions wouldrequire separate hermetic feed through connections that addsconsiderable costs. The 2.4 GHz aspect of the antenna is an electricallylarge antenna that works well with most MICS antenna implementations.

Temperature Sensor(s) 158

One temperature sensor will be use for sensing the temperature of thebattery and one sensing the encapsulation. It is also possible toconnect one or more external temperature sensors. The sensor accuracy istypically +/−0.5 degrees between −30-+70 degrees and better than +/−0.25degrees between 20-45 degrees.

Pressure Sensors(s) 160

One or more pressure sensors 160 are connected to an A/D input of theMCU 52. The pressure sensors preferably have a sensing range of 0-2bars. The sensors can be of the SMD 3000 series type 3SC-0500-5212 fromMerit Sensor Systems.

Motor Controller(s) 162

One or more motors can be connected to the control assembly 1110. Theoperation of these motors are controlled by means of a respective motorcontroller. In a preferred embodiment, this motor controller consists of5 H-bridge with current measurement and rotation sensing. The controloptions are forward, backward, or break. The control is either ON orOFF, i.e., no speed control is implemented. Alternatively, speed controlcan be implemented, such as by means of a pulse width modulated (PWM)signal.

In order to conserve power, a select signal to each motors currentfeedback needs to be activated before any measurements can be done.

The current through the motor is measured in order to differentiate fourstates:

Normal running operation

Motor stall

Motor short-circuit/open circuit

Slipping of magnetic clutch

Different mechanics and motors will have different thresholds for thestates. This will be evaluated by software.

The rotation of the motors will be monitored either by an internalencoder in the motor or by external sensors/encoders. The sensing of themovement can be done with a low power Hall element, for example AllegroA139X series, in combination with a comparator that sets the sensitivityor by optical encoders depending on the mechanics. There are two sensorsfor each motor to be able to determine both speed and direction. Endswitches can optionally be provided.

Depending on the mechanics and the motors different rotation sensingmethods can be used. Exact trip points and hysteresis are applicationdependent. It should be noted that the mentioned sensors are merelyexamples and that more types can be added.

Sensing on outgoing axle can be used when there is no encoder on themotor. The rotation sensing can be done with two Hall-effect sensors,such as A1391SE sensors from Allegro Micro Systems, Inc. By using twosensors per motor both direction and speed can be determined. The phasebetween the detectors shall be 90 degrees, which is set by themechanical mounting of the devices.

Alternatively, a reflex detector can be used for rotation sensing.

In yet an alternative embodiment, an integrated encoder in the motor canbe used for rotation determination.

Stimuli Generator(s) 164

The control assembly can be adapted to control the operation of animplanted medical device in the form of one or more electrodes used toelectrically stimulate an organ in the patient' body, such as thecorpora cavernosa or crura or the prolongations thereof of a malepatient's penile tissue, the colon, rectum, or anus or the prolongationthereof, the urine bladder, the urethra or the prolongation thereof, orany other bodily lumen which requires electrical stimulation undercontrol of the patient or a doctor.

The stimuli generators 164 are designed around a high speed, highcurrent output operational amplifiers, such as the AD825 from AnalogDevices, Inc. Each output has a dc current blocking capacitor. A DCservo prevents the capacitor to charge due to offset current errors

In one embodiment, the implanted medical device contains 4+4 electrodesto which a constant current pulse generator is connected. The currentgenerator can be connected to two or several electrodes simultaneously.

The current pulses always consist of one positive current pulse and onenegative current pulse in any order. The stimuli pulses are configurableregarding current amplitude; pulse widths, number of pulses in a pulsetrain and pulse frequency. The control assembly 1110 ensures that thepulses are charged balanced.

The software of the computer 112 is adapted to write configurationparameters to the control assembly 1110 and to start and stopstimulation with those parameters. The stimulation can “move” betweendifferent electrodes to e.g. create an artificial peristalsis.

In a preferred embodiment, the stimuli amplitude is be up to 20 mA with+/−14V available.

Capacitor Measurement Device 166

One or more capacitance measuring inputs are provided for determinationof a physical or mechanical position. The input has a working range of5-100 pF.

Motion Sensor 168

The motion sensor is a piezo polymer strip that generates acharge/voltage during movement of an intestine. Each motion sensor isadjusted depending of the application in order to apply an appropriategain.

The first unit 120 could comprises an injection port 170 adapted toreceive an injection needle. The injection port comprises a reservoirwith a silicone septum. Fluid is added to or removed from the interiorreservoir of the first unit 120 by inserting a Huber needlepercutaneously into the septum. Although the septum is made of silicone,the means of the injection port for receiving a needle includes anystructure configured to self seal after puncture with a non-coringneedle.

Different systems comprising an assembly 1110 will now be described.

FIG. 25 illustrates a system for treating a disease comprising animplanted medical device 100 placed in the abdomen of a patient. Animplanted energy-transforming device 1002, corresponding to the controlassembly 1110, is adapted to supply energy consuming components of theapparatus with energy via a power supply line 1003. An externalenergy-transmission device 1004, corresponding to the energizer 110, fornon-invasively energizing the implanted medical device 100 transmitenergy by at least one wireless energy signal. The implantedenergy-transforming device 1002 transforms energy from the wirelessenergy signal into electric energy which is supplied via the powersupply line 1003.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 1004 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 1002 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 1004 into energy of a second form, whichtypically is different from the energy of the first form. The implantedmedical device 100 is operable in response to the energy of the secondform. The energy-transforming device 1002 may directly power theapparatus with the second form energy, as the energy-transforming device1002 transforms the first form energy transmitted by theenergy-transmission device 1004 into the second form energy. The systemmay further include an implantable accumulator, wherein the second formenergy is used at least partly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 1004 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 1004. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 1004 maybe used to directly power the operation device to create kinetic energyfor the operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 1002 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatients body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patients body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 1004 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 1002 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmit an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 26 illustrates the system of FIG. 25 in the form of a moregeneralized block diagram showing the implanted medical device 100, theenergy-transforming device 1002 powering the implanted medical device100 via power supply line 1003, and the external energy-transmissiondevice 1004, The patients skin 1005, generally shown by a vertical line,separates the interior of the patient to the right of the line from theexterior to the left of the line.

FIG. 27 shows an embodiment of the invention identical to that of FIG.26, except that a reversing device in the form of an electric switch1006 operable for example by polarized energy also is implanted in thepatient for reversing the implanted medical device 100. When the switchis operated by polarized energy the wireless remote control of theexternal energy-transmission device 1004 transmit a wireless signal thatcarries polarized energy and the implanted energy-transforming device1002 transforms the wireless polarized energy into a polarized currentfor operating the electric switch 1006. When the polarity of the currentis shifted by the implanted energy-transforming device 1002 the electricswitch 1006 reverses the function performed by the implanted medicaldevice 100.

FIG. 28 shows an embodiment of the invention identical to that of FIG.26, except that an operation device 1007 implanted in the patient foroperating the implanted medical device 100 is provided between theimplanted energy-transforming device 1002 and the implanted medicaldevice 100. This operation device can be in the form of a motor 1007,such as an electric servomotor. The motor 1007 is powered with energyfrom the implanted energy-transforming device 1002, as the remotecontrol of the external energy-transmission device 1004 transmit awireless signal to the receiver of the implanted energy-transformingdevice 1002.

FIG. 29 shows an embodiment of the invention identical to that of FIG.26, except that it also comprises an operation device is in the form ofan assembly 1008 including a motor/pump unit 1009 and a fluid reservoir1010 is implanted in the patient. In this case the implanted medicaldevice 100 is hydraulically operated, i.e. hydraulic fluid is pumped bythe motor/pump unit 1009 from the fluid reservoir 1010 through a conduit1011 to the implanted medical device 100 to operate the apparatus, andhydraulic fluid is pumped by the motor/pump unit 1009 back from theimplanted medical device 100 to the fluid reservoir 1010 to return theapparatus to a starting position. The implanted energy-transformingdevice 1002 transforms wireless energy into a current, for example apolarized current, for powering the motor/pump unit 1009 via an electricpower supply line 1012.

Instead of a hydraulically operated apparatus 1110, it is also envisagedthat the operation device comprises a pneumatic operation device. Inthis case, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 1002 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patients hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 30 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with it wireless remote control, theapparatus 1110, in this case hydraulically operated, and the implantedenergy-transforming device 1002, and further comprising a hydraulicfluid reservoir 1013, a motor/pump unit 1009 and an reversing device inthe form of a hydraulic valve shilling device 1014, all implanted in thepatient. Of course the hydraulic operation could easily be performed byjust changing the pumping direction and the hydraulic valve maytherefore be omitted. The remote control may be a device separated fromthe external energy-transmission device or included in the same. Themotor of the motor/pump unit 1009 is an electric motor. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the implanted energy-transformingdevice 1002 powers the motor/pump unit 1009 with energy from the energycarried by the control signal, whereby the motor/pump unit 1009distributes hydraulic fluid between the hydraulic fluid reservoir 1013and the apparatus 10. The remote control of the externalenergy-transmission device 1004 controls the hydraulic valve shillingdevice 1014 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 1009 fromthe hydraulic fluid reservoir 1013 to the implanted medical device 100to operate the apparatus, and another opposite direction in which thefluid is pumped by the motor/pump unit 1009 back from the implantedmedical device 100 to the hydraulic fluid reservoir 1013 to return theapparatus to a starting position.

FIG. 31 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, theapparatus 1110, the implanted energy-transforming device 1002, animplanted internal control unit 1015 controlled by the wireless remotecontrol of the external energy-transmission device 1004, an implantedaccumulator 1016 and an implanted capacitor 1017. The internal controlunit 1015 arranges storage of electric energy received from theimplanted energy-transforming device 1002 in the accumulator 1016, whichsupplies energy to the apparatus 1110. In response to a control signalfrom the wireless remote control of the external energy-transmissiondevice 1004, the internal control unit 1015 either releases electricenergy from the accumulator 1016 and transfers the released energy viapower lines 1018 and 1019, or directly transfers electric energy fromthe implanted energy-transforming device 1002 via a power line 1020, thecapacitor 1017, which stabilizes the electric current, a power line 1021and the power line 1019, for the operation of the apparatus 1110.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the implanted medical device 100 according to apre-programmed time-schedule or to input from any sensor sensing anypossible physical parameter of the patient or any functional parameterof the system.

In accordance with an alternative, the capacitor 1017 in the embodimentof FIG. 31 may be omitted. In accordance with another alternative, theaccumulator 1016 in this embodiment may be omitted.

FIG. 32 shows an embodiment of the invention identical to that of FIG.16, except that a battery 1022 for supplying energy for the operation ofthe implanted medical device 100 and an electric switch 1023 forswitching the operation of the implanted medical device 100 also areimplanted in the patient. The electric switch 1023 may be controlled bythe remote control and may also be operated by the energy supplied bythe implanted energy-transforming device 1002 to switch from an offmode, in which the battery 1022 is not in use, to an on mode, in whichthe battery 1022 supplies energy for the operation of the apparatus1110.

FIG. 33 shows an embodiment of the invention identical to that of FIG.32, except that an internal control unit 1015 controllable by thewireless remote control of the external energy-transmission device 1004also is implanted in the patient. In this case, the electric switch 1023is operated by the energy supplied by the implanted energy-transformingdevice 1002 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 1015 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 1015 torelease electric energy from the battery 1022 for the operation of theapparatus 1110.

FIG. 34 shows an embodiment of the invention identical to that of FIG.18, except that an accumulator 1016 is substituted for the battery 1022and the implanted components are interconnected differently. In thiscase, the accumulator 1016 stores energy from the implantedenergy-transforming device 1002. In response to a control signal fromthe wireless remote control of the external energy-transmission device1004, the internal control unit 1015 controls the electric switch 1023to switch from an off mode, in which the accumulator 1016 is not in use,to an on mode, in which the accumulator 1016 supplies energy for theoperation of the apparatus 10. The accumulator may be combined with orreplaced by a capacitor.

FIG. 35 shows an embodiment of the invention identical to that of FIG.34, except that a battery 1022 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 controlsthe accumulator 1016 to deliver energy for operating the electric switch1023 to switch from an off mode, in which the battery 1022 is not inuse, to an on mode, in which the battery 1022 supplies electric energyfor the operation of the apparatus 1110.

Alternatively, the electric switch 1023 may be operated by energysupplied by the accumulator 1016 to switch from an off mode, in whichthe wireless remote control is prevented from controlling the battery1022 to supply electric energy and is not in use, to a standby mode, inwhich the wireless remote control is permitted to control the battery1022 to supply electric energy for the operation of the apparatus 1110.

It should be understood that the switch 1023 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 36 shows an embodiment of the invention identical to that of FIG.32, except that a motor 1007, a mechanical reversing device in the formof a gear box 1024, and an internal control unit 1015 for controllingthe gear box 1024 also are implanted in the patient. The internalcontrol unit 1015 controls the gear box 1024 to reverse the functionperformed by the implanted medical device 100 (mechanically operated).Even simpler is to switch the direction of the motor electronically. Thegear box interpreted in it broadest embodiment may stand for a servoarrangement saving force for the operation device in favor of longerstroke to act.

FIG. 37 shows an embodiment of the invention identical to that of FIG.36 except that the implanted component are interconnected differently.Thus, in this case the internal control unit 1015 is powered by thebattery 1022 when the accumulator 1016, suitably a capacitor, activatesthe electric switch 1023 to switch to an on mode. When the electricswitch 1023 is inks on mode the internal control unit 1015 is permittedto control the battery 1022 to supply, or not supply, energy for theoperation of the apparatus 1110.

FIG. 38 schematically shows conceivable combinations of implantedcomponent of the apparatus for achieving various communication options.Basically, there are the apparatus 1110, the internal control unit 1015,motor or pump unit 1009, and the external energy-transmission device1004 including the external wireless remote control. As alreadydescribed above the wireless remote control transmit a control signalwhich is received by the internal control unit 1015, which in turncontrols the various implanted component of the apparatus.

A feedback device, preferably comprising a sensor or measuring device1025, may be implanted in the patient for sensing a physical parameterof the patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 1025 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, any electrical parameter, pressure, volume,diameter, stretc, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 1015, or alternatively the external wirelessremote control of the external energy-transmission device 1004, maycontrol the implanted medical device 100 in response to signals from thesensor 1025. A transceiver may be combined with the sensor 1025 forsending information on the sensed physical parameter to the externalwireless remote control. The wireless remote control may comprise asignal transmitter or transceiver and the internal control unit 1015 maycomprise a signal receiver or transceiver. Alternatively, the wirelessremote control may comprise a signal receiver or transceiver and theinternal control unit 1015 may comprise a signal transmitter ortransceiver. The above transceivers, transmitters and receivers may beused for sending information or data related to the implanted medicaldevice 100 from inside the patients body to the outside thereof.

Where the motor/pump unit 1009 and battery 1022 for powering themotor/pump unit 1009 are implanted, information related to the chargingof the battery 1022 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 39 shows an alternative embodiment wherein the implanted medicaldevice 100 is regulated from outside the patients body. The system 1000comprises a battery 1022 connected to the implanted medical device 100via a subcutaneous electric switch 1026. Thus, the regulation of theimplanted medical device 100 is performed non-invasively by manuallypressing the subcutaneous switch, whereby the operation of the implantedmedical device 100 is switched on and off. It will be appreciated thatthe shown embodiment is a simplification and that additional component,such as an internal control unit or any other part disclosed in thepresent application can be added to the system. Two subcutaneousswitches may also be used. In the preferred embodiment one implantedswitch sends information to the internal control unit to perform acertain predetermined performance and when the patient press the switchagain the performance is reversed.

FIG. 40 shows an alternative embodiment, wherein the system 1000comprises a hydraulic fluid reservoir 1013 hydraulically connected tothe apparatus. Non-invasive regulation is performed by manually pressingthe hydraulic reservoir connected to the apparatus.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to theapparatus or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.

FIG. 41 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patients body to theoutside thereof to give feedback information related to at least onefunctional parameter of the apparatus or system, or related to aphysical parameter of the patient, in order to supply an accurate amountof energy to an implanted internal energy receiver 1002 connected toimplanted energy consuming component of the apparatus 1110. Such anenergy receiver 1002 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 1004 a located outside thepatient and is received by the internal energy receiver 1002 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentof the implanted medical device 100 via a switch 1026. An energy balanceis determined between the energy received by the internal energyreceiver 1002 and the energy used for the apparatus 1110, and thetransmission of wireless energy is then controlled based on thedetermined energy balance. The energy balance thus provides an accurateindication of the correct amount of energy needed, which is sufficientto operate the implanted medical device 100 properly, but withoutcausing undue temperature rise.

In FIG. 41 the patients skin is indicated by a vertical line 1005. Here,the energy receiver comprises an energy-transforming device 1002 locatedinside the patient, preferably just beneath the patient's skin 1005.Generally speaking, the implanted energy-transforming device 1002 may beplaced in the abdomen, thorax, muscle fascia (e.g. in the abdominalwall), subcutaneously, or at any other suitable location. The implantedenergy-transforming device 1002 is adapted to receive wireless energy Etransmitted from the external energy-source 1004 a provided in anexternal energy-transmission device 1004 located outside the patientsskin 1005 in the vicinity of the implanted energy-transforming device1002.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Munster (TET)device, such as a device including a primary coil arranged in theexternal energy source 1004 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 1002. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming component of the apparatus, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted component of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted component of the apparatus. A control deviceincludes an external control unit 1004 b that controls the externalenergy source 1004 a based on the determined energy balance to regulatethe amount of transferred energy. In order to transfer the correctamount of energy, the energy balance and the required amount of energyis determined by means of a determination device including an implantedinternal control unit 1015 connected between the switch 1026 and theapparatus 1110. The internal control unit 1015 may thus be arranged toreceive various measurements obtained by suitable sensors or the like,not shown, measuring certain characteristics of the apparatus 1110,somehow reflecting the required amount of energy needed for properoperation of the apparatus 1110. Moreover, the current condition of thepatient may also be detected by means of suitable measuring devices orsensors, in order to provide parameters reflecting the patient'scondition. Hence, such characteristics and/or parameters may be relatedto the current state of the apparatus 1110, such as power consumption,operational mode and temperature, as well as the patients conditionreflected by parameters such as; body temperature, blood pressure,heartbeats and breathing. Other kinds of physical parameters of thepatient and functional parameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 1016 mayoptionally be connected to the implanted energy-transforming device 1002via the control unit 1015 for accumulating received energy for later useby the apparatus 1110. Alternatively or additionally, characteristics ofsuch an accumulator, also reflecting the required amount of energy, maybe measured as well. The accumulator may be replaced by a rechargeablebattery, and the measured characteristics may be related to the currentstate of the battery, any electrical parameter such as energyconsumption voltage, temperature, etc. In order to provide sufficientvoltage and current to the apparatus 1110, and also to avoid excessiveheating, it is clearly understood that the battery should be chargedoptimally by receiving a correct amount of energy from the implantedenergy-transforming device 1002, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 1015. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 1015 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus 1110, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit1015 is further connected to an internal signal transmitter 1027,arranged to transmit a control signal reflecting the determined requiredamount of energy, to an external signal receiver 1004 c connected to theexternal control unit 1004 b. The amount of energy transmitted from theexternal energy source 1004 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 1004 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 1004 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 1004 b, thus integrating the above-describedfunction of the internal control unit 1015 in the external control unit1004 b. In that case, the internal control unit 1015 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 1027 which sends the measurements over to the externalsignal receiver 1004 c and the external control unit 1004 b. The energybalance and the currently required amount of energy can then bedetermined by the external control unit 1004 b based on those sensormeasurements.

Hence, the present solution according to the arrangement of FIG. 41employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming component of the apparatus. The apparatus may use thereceived energy either for consuming or for storing the energy in animplanted energy source or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken internally to specificallyoperate the apparatus.

The internal signal transmitter 1027 and the external signal receiver1004 c may be implemented as separate unit using suitable signaltransfer means, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 1027 and the externalsignal receiver 1004 c may be integrated in the implantedenergy-transforming device 1002 and the external energy source 1004 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmit wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 41, the switch 1026is either separate and controlled by the internal control unit 1015, orintegrated in the internal control unit 1015. It should be understoodthat the switch 1026 should be interpreted in it broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 41 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 1015 of the determinationdevice. A control signal reflecting the required amount of energy isalso created by the internal control unit 1015, and the control signalis transmitted from the internal signal transmitter 1027 to the externalsignal receiver 1004 c. Alternatively, the energy balance can bedetermined by the external control unit 1004 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement result from various sensors. The amount of energyemitted from the external energy source 1004 a can then be regulated bythe external control unit 1004 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 1004 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 42, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 42,wherein an external switch 1026 is interconnected between the externalenergy source 1004 a and an operation device, such as an electric motor1007 operating the apparatus 1110. An external control unit 1004 bcontrols the operation of the external switch 1026 to effect properoperation of the apparatus 1110.

FIG. 43 illustrates different embodiments for how received energy can besupplied to and used by the apparatus 1110. Similar to the example ofFIG. 41, an internal energy receiver 1002 receives wireless energy Efrom an external energy source 1004 a which is controlled by atransmission control unit 1004 b. The internal energy receiver 1002 maycomprise a constant voltage circuit, indicated as a dashed box “constantV” in the figure, for supplying energy at constant voltage to theapparatus 1110. The internal energy receiver 1002 may further comprise aconstant current circuit, indicated as a dashed box “constant C” in thefigure, for supplying energy at constant current to the apparatus 1110.

The implanted medical device 100 comprises an energy consuming part 100a, which may be a motor, pump, restriction device, or any other medicalappliance that requires energy for its electrical operation. Theimplanted medical device 100 may further comprise an energy storagedevice 100 b for storing energy supplied from the internal energyreceiver 1002. Thus, the supplied energy may be directly consumed by theenergy consuming part 100 a, or stored by the energy storage device 100b, or the supplied energy may be partly consumed and partly stored. Theimplanted medical device 100 may further comprise an energy stabilizingunit 100 c for stabilizing the energy supplied from the internal energyreceiver 1002. Thus, the energy may be supplied in a fluctuating mannersuch that it may be necessary to stabilize the energy before consumed orstored.

The energy supplied from the internal energy receiver 1002 may furtherbe accumulated and/or stabilized by a separate energy stabilizing unit1028 located outside the apparatus 1110, before being consumed and/orstored by the apparatus 1110. Alternatively, the energy stabilizing unit1028 may be integrated in the internal energy receiver 1002. In eithercase, the energy stabilizing unit 1028 may comprise a constant voltagecircuit and/or a constant current circuit.

It should be noted that FIG. 41 and FIG. 43 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional component and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the present invention.

FIG. 44 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted components of theapparatus, more energy is transferred and thus charged into the energysource. The output signal from the circuit is typically feed to an A/Dconverter and converted into a digital format. The digital informationcan then be sent to the external energy-transmission device allowing itto adjust the level of the transmitted energy. Another possibility is tohave a completely analog system that uses comparators comparing theenergy balance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 44 shows a circuit implementation for a system thattransfers energy to the implanted energy component of the apparatus ofthe present invention from outside of the patients body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, L1, is included in the schematic FIG. 27; the transmitting part ofthe system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 44and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

In FIG. 43 the symbols Y1, Y2, Y3 and so on symbolize test point withinthe circuit. The component in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted component is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 1006 of FIG. 27 could be incorporated in any of theembodiments of FIGS. 30-36, the hydraulic valve shilling device 1014 ofFIG. 30 could be incorporated in the embodiment of FIG. 29, and the gearbox 1024 could be incorporated in the embodiment of FIG. 28. Pleaseobserve that the switch simply could mean any electronic circuit orcomponent.

The embodiments described in connection with FIGS. 41, 43 and 44identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming component of an electricallyoperable apparatus. Such a method and system will be defined in generalterms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming component of an apparatusas described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming component ofthe apparatus for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the apparatus. Thetransmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physical parameters of the medical device and/orphysical parameters of the patient are determined, the energy may betransmitted for consumption and storage according to a transmission rateper time unit which is determined based on said parameters. The totalamount of transmitted energy may also be determined based on saidparameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising an apparatus as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming component of the apparatus. In it broadestsense, the system comprises a control device for controlling thetransmission of wireless energy from an energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming component of the apparatus for directly orindirectly supplying received energy thereto. The system furthercomprises a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming component of theapparatus, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming component of        the apparatus, and the control device controls the transmission        of wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for the apparatus is consumed to operate the        apparatus, and/or stored in at least one energy storage device        of the apparatus.    -   Where electrical and/or physical parameters of the apparatus        and/or physical parameters of the patient are determined, the        energy-transmission device transmit the energy for consumption        and storage according to a transmission rate per time unit which        is determined by the determination device based on said        parameters. The determination device also determines the total        amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIGS. 36-39 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted apparatus accordingto the invention.

FIG. 45 shows a system as described above with. The system comprises animplanted medical device 100 and further a separate regulation reservoir1013, a one way pump 1009 and an alternate valve 1014.

FIG. 46 shows the implanted medical device 100 and a fluid reservoir1013. By moving the wall of the regulation reservoir or changing thesize of the same in any other different way, the adjustment of theapparatus may be performed without any valve, just free passage of fluidany time by moving the reservoir wall.

FIG. 47 shows the apparatus 1110, a two way pump 1009 and the regulationreservoir 1013.

FIG. 48 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 1013 and a servo reservoir 1050. Theservo reservoir 1050 mechanically controls an implanted medical device100 via a mechanical interconnection 1054. The apparatus has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 1052 in fluid connection with the apparatus 10. Alternatively,the cavity contains compressible gas, which can be compressed andexpanded under the control of the servo reservoir 1050.

The servo reservoir 1050 can also be part of the apparatus itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patients skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 49 a-c. InFIG. 49 a, a flexible subcutaneous regulation reservoir 1013 is shownconnected to a bulge shaped servo reservoir 1050 by means of a conduit1011. This bellow shaped servo reservoir 1050 is comprised in a flexibleapparatus 1110. In the state shown in FIG. 49 a, the servo reservoir1050 contains a minimum of fluid and most fluid is found in theregulation reservoir 1013. Due to the mechanical interconnection betweenthe servo reservoir 1050 and the apparatus 1110, the outer shape of theimplanted medical device 100 is contracted, i.e., it occupies less thanits maximum volume. This maximum volume is shown with dashed lines inthe figure.

FIG. 49 b shows a state wherein a user, such as the patient in with theapparatus is implanted, presses the regulation reservoir 1013 so thatfluid contained therein is brought to flow through the conduit 1011 andinto the servo reservoir 1050, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the implantedmedical device 100 so that it occupies its maximum volume, therebystretching the stomach wall (not shown), which it contact.

The regulation reservoir 1013 is preferably provided with means 1013 afor keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the implanted medicaldevice 100 in a stretched position also when the user releases theregulation reservoir. In this way, the regulation reservoir essentiallyoperates as an on/off switch for the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 41 and 42 a-c. The block diagramshown in FIG. 50 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir1013 and a servo reservoir 1050. The servo reservoir 1050 mechanicallycontrols a larger adjustable reservoir 1052 via a mechanicalinterconnection 1054. An implanted medical device 100 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 1052 by supply of hydraulic fluid from the largeradjustable reservoir 1052 in fluid connection with the apparatus 1110.

An example of this embodiment will now be described with reference toFIG. 51 a-c. Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 1013 is in fluid connection with a bellow shaped servoreservoir 1050 by means of a conduit 1011. In the first closed system1013, 1011, 1050 shown in FIG. 51 a, the servo reservoir 1050 contains aminimum of fluid and most fluid is found in the regulation reservoir1013.

The servo reservoir 1050 is mechanically connected to a largeradjustable reservoir 1052, in this example also having a bellow shapebut with a larger diameter than the servo reservoir 1050. The largeradjustable reservoir 1052 is in fluid connection with the apparatus1110. This means that when a user pushes the regulation reservoir 1013,thereby displacing fluid from the regulation reservoir 1013 to the servoreservoir 1050, the expansion of the servo reservoir 1050 will displacea larger volume of fluid from the larger adjustable reservoir 1052 tothe apparatus 10. In other words, in this reversed servo, a small volumein the regulation reservoir is compressed with a higher force and thiscreates a movement of a larger total area with less force per area unit.

Like in the previous embodiment described above with reference to FIGS.40 a-c, the regulation reservoir 1013 is preferably provided with means1013 a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the implanted medicaldevice 100 in a stretched position also when the user releases theregulation reservoir. In this way, the regulation reservoir essentiallyoperates as an on/off switch for the system.

The control assembly can be placed in the body of a patient by differentmethods. One method comprises the steps of:

inserting a needle or tube like instrument into the abdomen of thepatients body,

using the needle or tube like instrument to fill the abdomen with gasthereby expanding the abdominal cavity,

placing at least two laparoscopic trocars in the patients body,

inserting a camera through one of the trocars into the abdomen,

inserting at least one dissecting tool through a trocar and dissectingan area of a body tissue of the patient,

placing a first unit of the control assembly at a first side of the bodytissue of the patient,

placing a second unit of the control assembly at a second side of thebody tissue of the patient, and

placing an interconnecting device adapted for mechanical interconnectionof the first and second unit to keep the assembly in place by the bodytissue, the interconnecting device having a cross-sectional area whichis smaller than the cross-sectional area of the first unit and thesecond unit in a plane parallel to the extension of the body tissue.

Another method for placing a control assembly in a human or mammalpatient comprises the steps of:

cutting the skin of the patient

dissecting an area of a body tissue,

placing a first unit of the control assembly at a first side of the bodytissue of the patient,

placing a second unit of the control assembly at a second side of thebody tissue of the patient, and

placing an interconnecting device adapted for mechanical interconnectionof the first and second unit to keep the assembly in place by the bodytissue, the interconnecting device having a cross-sectional area whichis smaller than the cross-sectional area of the first unit and thesecond unit in a plane parallel to the extension of the body tissue.

Please note that any embodiment or part of embodiment as well as anymethod or part of method could be combined in any way. All examplesherein should be seen as part of the general description and thereforepossible to combine in any way in general terms.

The invention claimed is:
 1. An implantable medical device forlubrication of a synovial joint having a joint cavity, wherein saidimplantable device comprises: a solid lubricant, an implantablereplaceable cartridge adapted to have an opening into the joint cavity,when implanted, an implantable mechanical feeding device, wherein saidimplantable mechanical feeding device is adapted to feed said solidlubricant into the joint cavity for lubricating the synovial joint, andwherein the mechanical feeding device is adapted to propel the solidlubricant, thereby feeding the solid lubricant into the joint, whenimplanted, and a system for manually and non-invasively controlling themedical device, comprising at least one of; at least one switchimplantable in the patient, a wireless remote control, and animplantable hydraulic reservoir which is hydraulically connected to theimplantable medical device and adapted to be regulated by manuallypressing the hydraulic reservoir, wherein the system further comprises asensor and/or a measuring device for sensing or measuring at least oneof: at least one physical parameter of the patient, and at least onefunctional parameter related to the implantable medical device andcomprising at least one of: a functional parameter correlated to atransfer of energy for charging an internal energy source, and afunctional parameter related to the implantable medical device, whereinthe implantable medical device further comprises a feedback device forsending feedback information from inside the patient's body to at leastone of: an implantable internal control unit, an external control unitoutside of the patient's body, an external control unit outside of thepatient's body, via the internal control unit, and an external controlunit outside of the patient's body, via the internal control unitaccording to a programming of the internal control unit performed by theexternal control unit, wherein the feedback information is related to atleast one of: the at least one physical parameter of the patient and theat least one functional parameter related to the implantable medicaldevice.
 2. The implantable medical device according to claim 1, whereinsaid solid lubricant has shear thinning properties, such that theviscosity of said solid lubricant is reduced when said solid lubricantis exposed to strain in the joint cavity.
 3. The implantable medicaldevice according to claim 1, wherein said solid lubricant comprises atleast one of: high-molecular weight hyaluronic acid, crosslinkedhigh-molecular weight hyaluronic acid, and hyaluronic acid of at leasttwo different high-molecular weights, crosslinked to form a solid gel.4. The implantable medical device according to claim 1, wherein saidsolid lubricant comprises a crosslinking agent chosen from1,2,3,4-diepoxybutane, divinyl sulfone.
 5. The implantable medicaldevice according to claim 1, wherein said solid lubricant comprises ahydrophilic polymer chosen from synthetic and natural polysaccharides.6. The implantable medical device according to claim 5, wherein saidhydrophilic polymer comprises a hydrophilic polymer selected from agroup consisting of: a. hydroxyethyl cellulose, b. camoxymethylcellulose, c. xanthan gum, d. chondroitin sulfate, e. heparin, f.protein, g. sulfated protein, h. synthetic water-soluble polymers. 7.The implantable medical device according to claim 6, wherein saidprotein comprises a protein selected from a group consisting of: a.collagen, b. elastin, c. albumin, and d. a globulin.
 8. The implantablemedical device according to claim 6, wherein said sulfated proteincomprises a sulfated protein selected from a group consisting of: a.keratin sulfate, and b. sulfated aminoglycosaminoglycans.
 9. Theimplantable medical device according td claim 6, wherein said syntheticwater-soluble polymer is a synthetic water-soluble polymer selected froma group consisting of: a. polyvinyl alcohol, b. co-polymers of polyvinylalcohol, and c. co-polymers of poly-(hydroxyethyl)methacrylate.
 10. Theimplantable medical device according to claim 1, wherein said medicaldevice is adapted to be implanted in the area of the hip joint, suchthat said solid lubricant can be inserted into the joint cavity of thehip joint.
 11. The implantable medical device according to claim 10,wherein said medical device is adapted to at least partially beimplanted in the caput femur, such that the feeding device can feed thesolid lubricant into the hip joint cavity, towards the acetabulum. 12.The implantable medical device according to claim 10, wherein theimplantable device is adapted to be inserted into a bore in the femoralbone.
 13. The implantable medical device according to claim 10, whereinsaid medical device is adapted to at least partially be implanted in thepelvis, such that the feeding device can feed the solid lubricant intothe hip joint cavity, towards the caput femur.
 14. The implantablemedical device according to claim 1, further comprising a retentionmember for retaining the medical device inside of a bore, wherein saidretention member comprises at least one of; at least one bone contactingportion adapted to press on the bone of the inside of the bore forretaining said medical device in the bore, and at least one springmember adapted to exert force on said at least one bone contactingportion.
 15. The implantable medical device according to claim 1,wherein said feeding device comprises at least one of; an energizedfeeding device, an energized feeding device comprising a motor, anelastic member, an elastic member being a spring member, and anadaptation to be powered by a pressurized gaseous fluid.
 16. Theimplantable medical device according to claim 1, wherein said medicaldevice comprises a cartridge being adapted to be exchanged when saidsolid lubricant housed inside said cartridge has been used up.
 17. Theimplantable medical device according to claim 1, wherein the implantablemedical device further comprises an implantable sleeve adapted to beplaced within a bone of the patient, and further adapted to receive saidimplantable medical device.
 18. The implantable medical device accordingto claim 1, further comprising a system, comprising at least one of; aninternal energy source for powering the implantable medical device, andan internal energy receiver and an adaptation to be energizednon-invasively and wirelessly by an energy transmission device fromoutside the patient's body, wherein the energy transmission device isadapted for sending wireless energy to at least one of: an implantableinternal energy source or energy storage comprised in the system, beingchargeable by the energy transferred from the energy transmissiondevice, and at least one implantable energy consuming component of thesystem being energized with the wireless energy.